FDA recall D-0348-2023

RISING PHARMACEUTICALS · Class II · drug

Product

Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.

Key facts

Status
Terminated
Initiation date
2023-02-15
Report date
2023-03-01
Termination date
2024-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0348-2023